GI-102 Immunotherapy & Prostate Cancer: Phase 1 Trial with Janssen R&D Begins

GI Innovation and Janssen Launch Clinical Trial for Prostate Cancer Therapy

Berlin, Germany – In a significant development for prostate cancer treatment, South Korean biotech firm GI Innovation and Janssen R&D, a subsidiary of Johnson & Johnson, have initiated a clinical trial combining GI Innovation’s immunotherapy, GI-102, with Janssen’s T-cell engager, pasritumab (KLK2-CD3). The trial, focused on patients with advanced prostate cancer, represents a collaborative effort to explore new therapeutic avenues for a disease affecting millions globally. This partnership underscores the growing trend of pharmaceutical companies joining forces to accelerate the development of innovative cancer treatments.

The clinical trial, a Phase 1b/2 study, will evaluate the safety, tolerability, and anti-cancer activity of the combination therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after novel hormonal therapy (NHT). According to a press release from GI Innovation, the trial plans have been submitted to both the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) for review. Daum News reported the submissions on March 20, 2026.

Understanding Metastatic Castration-Resistant Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men worldwide. The National Cancer Institute provides comprehensive information on prostate cancer, its diagnosis, and treatment options. MCRPC is an advanced stage of the disease that occurs when cancer cells continue to grow even after hormonal therapy, which is a standard treatment for prostate cancer. This form of the disease is particularly challenging to treat, and new therapies are urgently needed to improve patient outcomes.

The Role of GI-102 and Pasritumab

GI-102 is an immune checkpoint inhibitor designed to enhance the body’s natural immune response against cancer cells. Immune checkpoint inhibitors work by blocking proteins that prevent the immune system from attacking cancer cells, effectively “releasing the brakes” on the immune system. Pasritumab, as well known as KLK2-CD3, is a T-cell engager, a type of immunotherapy that directs T cells – a crucial component of the immune system – to specifically target and destroy cancer cells expressing the KLK2 protein, which is often found on prostate cancer cells. The combination of these two therapies aims to provide a synergistic effect, maximizing the immune response against the tumor.

Collaboration and Supply Agreement

The initiation of this clinical trial follows a clinical supply agreement signed on March 17, 2026, between GI Innovation and Janssen R&D. Under the terms of the agreement, Janssen will provide pasritumab to GI Innovation at no cost, facilitating the conduct of the clinical trial. The Chosun Biz reported on this agreement, highlighting the collaborative nature of the project. This arrangement allows GI Innovation to focus on the clinical aspects of the trial while leveraging Janssen’s expertise in T-cell engager technology.

Trial Design and Objectives

The Phase 1b/2 clinical trial will be conducted in two stages: a safety confirmation stage and an expansion stage. The initial phase will focus on assessing the safety and tolerability of the combination therapy, while the expansion phase will evaluate its efficacy in a larger group of patients. The primary objectives of the trial are to determine the optimal dosage of the combination therapy and to assess its impact on tumor response, progression-free survival, and overall survival. Researchers will also be monitoring for any adverse events associated with the treatment.

GI Innovation’s Expanding Pipeline

GI Innovation is a biopharmaceutical company dedicated to the development of innovative immunotherapies for cancer. The company’s lead product candidate, GI-102, is currently being investigated in several clinical trials for various types of cancer. This collaboration with Janssen represents a significant milestone for GI Innovation, expanding the potential applications of GI-102 and accelerating the development of new cancer treatments. Edaily reported on the initiation of the trial, noting its potential to broaden the scope of GI-102’s application.

Implications for Prostate Cancer Treatment

The results of this clinical trial could have significant implications for the treatment of mCRPC. If the combination therapy proves to be safe and effective, it could offer a new hope for patients who have exhausted other treatment options. The development of novel immunotherapies is a rapidly evolving field, and this trial represents a step forward in harnessing the power of the immune system to fight cancer. The success of this collaboration could pave the way for further research and development of combination therapies for prostate cancer and other malignancies.

The trial’s progress will be closely watched by the medical community and patient advocacy groups. Further updates on the trial’s findings are expected as the study progresses. The next key milestone will be the completion of the Phase 1b safety assessment, which will determine whether the trial can proceed to the expansion phase.

Disclaimer: This article provides information for general knowledge and informational purposes only, and does not constitute medical advice. It is essential to consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.

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